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Dr. Abhishek Katakwar
MS, FIAGES, DMAS(Germany), FMBS
Fellow Bariatric and Metabolic Surgery, (Taiwan)
Bariatric & Metabolic surgeon
ASIAN INSTITUTE OF
GASTROENTEROLOGY, HYDERABAD
Bariatric consent
Secure Yourself first
..
 Martin D’Souza’s Case (1991)
 Potential candidate for renal transplant on HD
 UTI  amikacin deafness
 Difference in opinion of medical committee
 Doctor found guilty
Learning message
 Judges - lay men
 Police and Harassment of Doctors
 Consumer Courts
“Anuradha Saha”  11.5 Crores compensation (Judgment delivered on August 7, 2009 )
 “Making wrong diagnosis, prescribes medicines causing harm to the patient ”
 “Hospitals will be held guilty if they fail to provide essential amenities”
 “Doctors must keep up advancement of medical sciences and new diagnostics”
 “Higher level of medical care, a legitimate expectation from more reputed doctors and expensive
private hospitals”
 “A doctor is guilty if he treats a patient as an expert even though not specialist in that field”
 “Experts’ opinions are not binding on the court in medical negligence cases”
 “Hospitals/doctors are responsible for spreading of infection to the patients”
 “Doctors, whether permanent employees or just attending a patient, are equally responsible for
negligence”
 “A junior doctor cannot get away from his/her share of responsibility only because senior doctors
were treating the patient”
 ‘Doctors/hospitals must pay compensation even for death/injury to a housewife depending on her
education, status and husband’s income”
 “Doctors must follow medical protocol for treating patients”
 “A doctor must verify and be aware about the treatment that a patient has already
 received before embarking on using new medicines”
“Negligence is the breach of a duty caused by the
omission to do something which a reasonable man
would do, or doing something which a prudent
and reasonable man would not do, Causing injury
to his patient”
(i) lata culpa, gross neglect /recklessness – Criminal
(ii) levis culpa, ordinary neglect – civil
(iii) levissima culpa, slight neglect – considered
what is simple negligence and what is gross
negligence may not be so easy to be determined.
Experts may not agree on this because the
dividing line between the two is quite thin.
 IPC 304 A:Causing death by negligence, not
amounting to culpable homicide-two years
term, or with fine, or with both.
 Section 80 - Accident in doing a lawful Act
 Section 88 - Act not unintended to cause
death, done by consent in good faith for
person’s benefit
 Criminal negligence - “gross negligence” or
“recklessness”
 42% surgeons < one year experience Bx Sx
 26% <100 cases
 69% were ASMBS members
 Procedures
◦ RYGB: 78 % (open- 33%,Lap-45%)
◦ VBG : 3%
◦ MGB : 6 %
◦ BPD and DS : 4 %
◦ Revision : 9 %
◦ *No mention of LSG and LAGB
Mortality and morbidity
• Death :53 %
• Major disability :7 %
• Minor disability :12 %
• Full recovery :28 %
Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons.
Surg Obes Relat Dis 2007;3:60-67.
 In 28 of 100 cases potential negligence was found
– 82%  Delay in diagnosis
– 64% Misinterpreted vital signs
– 8 % Technical error in surgery
– 15 % “Dropped baton phenomenon”, primary
surgeon left town or transferred coverage
immediately before occurrence of complication:
Poor communication, inadequate training on part
of covering surgeon.
Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons.
Surg Obes Relat Dis 2007;3:60-67.
 22%  No comprehensive consent forms
 23 %  Noncompliant peri-operative recommendations
 7 % Cx due to dietary habit
 12 % Non compliant in follow up visit
 2 %  Fraudulent billing
 15 %  Inappropriate documentation
Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons.
Surg Obes Relat Dis 2007;3:60-67.
Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons.
Surg Obes Relat Dis 2007;3:60-67.
Areas of litigation in bariatric surgery
 Faulty patient screening and education.
 Delay in recognition and treatment of complications.
 Technical errors :less common issue.
 Inadequate training, hospital or office staffing.
 Inappropriate credentialing and deficiencies of informed
consent.
 Public awareness: even doctors
 Relatively new surgery
 ?? Cosmetic surgery
 Unrealistic propaganda
 Certified training programs
 Standardized care/protocols
 No insurance/high cost/disparity
 Media reporting
 Taining,Infrastructure, Equipments, Team
 NIH criteria for patient selection must be met
 Preoperative screening, evaluation and medical clearance
 Comprehensive medical/psychological evaluation
 Education Reeducation
◦ Pre and post Sx in hospital
◦ Various stages of recovery and dietary progression
◦ Long-term follow-up
 The patient signs a contract that covers post-operative behaviors and acknowledges their
responsibility in maintaining their health. The patient also signs a video completion certification to
acknowledge that they have
watched the videos and have understood the material.
 The patient’s relative also signs a letter of support
Behaviors that are expected after surgery
 Failure of Weight loss program previously
 Following up appropriately
 Following Diet plan
 Life style modification
 Taking proper vitamins and supplements
 Avoiding negative behaviors like smoking and ingestion of caustic substances, etc.
 These are non-binding, but serve to emphasize the importance of these factors in the patient’s
long-term well-being, and can be used in the court of law, another way that the patient
understood these things heading into surgery.
 The patient can be shown to have been a true and willing partner in the decision-making process.
 The patient’s family is included in this process.
 Integral part of WLS program
◦ improve the doctor-patient relationship,
◦ improve outcomes, and patient confidence
 Is a process not just a piece of paper
◦ Public Education Seminar
◦ Support Group attendance
◦ On Line Chat/message boards
◦ Commercial Web Sites
 Psychological Evaluation
 Surgeon Consultation
 Written consent and motivation assessment
 Realistic Risk Estimate
 Short/long term risks and complications
 Realistic estimates of short and long-term weight loss, potential for weight regain
 Inform them if long-term data (>5 years) are unavailable
 long-term health benefits of weight loss produced by WLS
 Not all preexisting medical and psychosocial consequences of obesity will improve with
WLS
 Patient expectations and the risks each candidate is willing to accept
 Behavioral and dietary changes
 Quality of life in a substantive way e.g. gastrointestinal symptoms, cosmetic effects,
nutritional restrictions
 Evaluate each patient’s comprehension of the risks, benefits, consequences
ASMBS criteria for bariatric surgeon
◦ Fellow participated in 100 weight loss operations
 Patient education, support group participation
 Experience with different surgical techniques
 Post- operative follow-up, monitoring of outcomes
 Diagnosis and treatment of complications
 Endoscopy and interventional radiology exposure
◦ Non-fellowship
 Documented training in an approved Bariatric Center (>200
procedure/year,>5 year)
IFSO Statement: Credentials for Bariatric Surgeons, Maurizio De Luca, Jacques Himpens,Rudolf
Weiner,Luigi Angrisani. 2015 OBES SURG (2015) 25:394–396
 Too much volume might impair the doctor/patient
relationship, thereby increasing the likelihood of subsequent
litigation, especially if the operating surgeon is buffered from
spending time with the patient.
 Interestingly, as the ASMBS moves toward a joint
certification process for Bariatric Surgery Centers of
Excellence, volumes are no longer a hard criterion for
qualification.
 Volume does appear to improve outcomes as long as the
volume attains a certain minimum level, but beyond that
doesn’t seem to continue to improve outcomes as volume
rises.
Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos GM.
Perioperative safety and volume: outcomes relationships in bariatric surgery:
a study of 32,000 patients. J Am Coll Surg. 2011 Dec;213(6):771-7
 “Indemnity” : reimbursement or to compensate
 Only civil not criminal negligence
 legal liability claims
 Defense cost :Expenditure
 Can insure whole team
 Unqualified staff errors, omissions, negligence
 No cover weight reduction drugs
Total 64 Bariatric
surgeon
•New India assurance:15
•United insurance: 13
•National insurance: 8
•Oriental insurance: 6
•Don’t know : 22
 Member of obesity society
 Protocol based practice (guidelines ASMBS)
 Proper documentation
 Consent – continuous process
 Second opinion – in case of doubt or
complications
 Insist for workshop certificates mentioning types
and no of surgeries.
 Insure yourself
Bariatric surgery and copra ossicon 2016 presentation

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Bariatric surgery and copra ossicon 2016 presentation

  • 1. Dr. Abhishek Katakwar MS, FIAGES, DMAS(Germany), FMBS Fellow Bariatric and Metabolic Surgery, (Taiwan) Bariatric & Metabolic surgeon ASIAN INSTITUTE OF GASTROENTEROLOGY, HYDERABAD Bariatric consent Secure Yourself first ..
  • 2.  Martin D’Souza’s Case (1991)  Potential candidate for renal transplant on HD  UTI  amikacin deafness  Difference in opinion of medical committee  Doctor found guilty Learning message  Judges - lay men  Police and Harassment of Doctors  Consumer Courts
  • 3. “Anuradha Saha”  11.5 Crores compensation (Judgment delivered on August 7, 2009 )  “Making wrong diagnosis, prescribes medicines causing harm to the patient ”  “Hospitals will be held guilty if they fail to provide essential amenities”  “Doctors must keep up advancement of medical sciences and new diagnostics”  “Higher level of medical care, a legitimate expectation from more reputed doctors and expensive private hospitals”  “A doctor is guilty if he treats a patient as an expert even though not specialist in that field”  “Experts’ opinions are not binding on the court in medical negligence cases”  “Hospitals/doctors are responsible for spreading of infection to the patients”  “Doctors, whether permanent employees or just attending a patient, are equally responsible for negligence”  “A junior doctor cannot get away from his/her share of responsibility only because senior doctors were treating the patient”  ‘Doctors/hospitals must pay compensation even for death/injury to a housewife depending on her education, status and husband’s income”  “Doctors must follow medical protocol for treating patients”  “A doctor must verify and be aware about the treatment that a patient has already  received before embarking on using new medicines”
  • 4. “Negligence is the breach of a duty caused by the omission to do something which a reasonable man would do, or doing something which a prudent and reasonable man would not do, Causing injury to his patient” (i) lata culpa, gross neglect /recklessness – Criminal (ii) levis culpa, ordinary neglect – civil (iii) levissima culpa, slight neglect – considered what is simple negligence and what is gross negligence may not be so easy to be determined. Experts may not agree on this because the dividing line between the two is quite thin.
  • 5.  IPC 304 A:Causing death by negligence, not amounting to culpable homicide-two years term, or with fine, or with both.  Section 80 - Accident in doing a lawful Act  Section 88 - Act not unintended to cause death, done by consent in good faith for person’s benefit  Criminal negligence - “gross negligence” or “recklessness”
  • 6.  42% surgeons < one year experience Bx Sx  26% <100 cases  69% were ASMBS members  Procedures ◦ RYGB: 78 % (open- 33%,Lap-45%) ◦ VBG : 3% ◦ MGB : 6 % ◦ BPD and DS : 4 % ◦ Revision : 9 % ◦ *No mention of LSG and LAGB Mortality and morbidity • Death :53 % • Major disability :7 % • Minor disability :12 % • Full recovery :28 % Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons. Surg Obes Relat Dis 2007;3:60-67.
  • 7.  In 28 of 100 cases potential negligence was found – 82%  Delay in diagnosis – 64% Misinterpreted vital signs – 8 % Technical error in surgery – 15 % “Dropped baton phenomenon”, primary surgeon left town or transferred coverage immediately before occurrence of complication: Poor communication, inadequate training on part of covering surgeon. Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons. Surg Obes Relat Dis 2007;3:60-67.
  • 8.  22%  No comprehensive consent forms  23 %  Noncompliant peri-operative recommendations  7 % Cx due to dietary habit  12 % Non compliant in follow up visit  2 %  Fraudulent billing  15 %  Inappropriate documentation Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons. Surg Obes Relat Dis 2007;3:60-67.
  • 9. Cottam D et al. Medico legal analysis of 100 malpractice claims against bariatric surgeons. Surg Obes Relat Dis 2007;3:60-67.
  • 10. Areas of litigation in bariatric surgery  Faulty patient screening and education.  Delay in recognition and treatment of complications.  Technical errors :less common issue.  Inadequate training, hospital or office staffing.  Inappropriate credentialing and deficiencies of informed consent.
  • 11.
  • 12.
  • 13.  Public awareness: even doctors  Relatively new surgery  ?? Cosmetic surgery  Unrealistic propaganda  Certified training programs  Standardized care/protocols  No insurance/high cost/disparity  Media reporting
  • 14.  Taining,Infrastructure, Equipments, Team  NIH criteria for patient selection must be met  Preoperative screening, evaluation and medical clearance  Comprehensive medical/psychological evaluation  Education Reeducation ◦ Pre and post Sx in hospital ◦ Various stages of recovery and dietary progression ◦ Long-term follow-up  The patient signs a contract that covers post-operative behaviors and acknowledges their responsibility in maintaining their health. The patient also signs a video completion certification to acknowledge that they have watched the videos and have understood the material.  The patient’s relative also signs a letter of support
  • 15. Behaviors that are expected after surgery  Failure of Weight loss program previously  Following up appropriately  Following Diet plan  Life style modification  Taking proper vitamins and supplements  Avoiding negative behaviors like smoking and ingestion of caustic substances, etc.  These are non-binding, but serve to emphasize the importance of these factors in the patient’s long-term well-being, and can be used in the court of law, another way that the patient understood these things heading into surgery.  The patient can be shown to have been a true and willing partner in the decision-making process.  The patient’s family is included in this process.
  • 16.  Integral part of WLS program ◦ improve the doctor-patient relationship, ◦ improve outcomes, and patient confidence  Is a process not just a piece of paper ◦ Public Education Seminar ◦ Support Group attendance ◦ On Line Chat/message boards ◦ Commercial Web Sites  Psychological Evaluation  Surgeon Consultation  Written consent and motivation assessment
  • 17.  Realistic Risk Estimate  Short/long term risks and complications  Realistic estimates of short and long-term weight loss, potential for weight regain  Inform them if long-term data (>5 years) are unavailable  long-term health benefits of weight loss produced by WLS  Not all preexisting medical and psychosocial consequences of obesity will improve with WLS  Patient expectations and the risks each candidate is willing to accept  Behavioral and dietary changes  Quality of life in a substantive way e.g. gastrointestinal symptoms, cosmetic effects, nutritional restrictions  Evaluate each patient’s comprehension of the risks, benefits, consequences
  • 18. ASMBS criteria for bariatric surgeon ◦ Fellow participated in 100 weight loss operations  Patient education, support group participation  Experience with different surgical techniques  Post- operative follow-up, monitoring of outcomes  Diagnosis and treatment of complications  Endoscopy and interventional radiology exposure ◦ Non-fellowship  Documented training in an approved Bariatric Center (>200 procedure/year,>5 year) IFSO Statement: Credentials for Bariatric Surgeons, Maurizio De Luca, Jacques Himpens,Rudolf Weiner,Luigi Angrisani. 2015 OBES SURG (2015) 25:394–396
  • 19.  Too much volume might impair the doctor/patient relationship, thereby increasing the likelihood of subsequent litigation, especially if the operating surgeon is buffered from spending time with the patient.  Interestingly, as the ASMBS moves toward a joint certification process for Bariatric Surgery Centers of Excellence, volumes are no longer a hard criterion for qualification.  Volume does appear to improve outcomes as long as the volume attains a certain minimum level, but beyond that doesn’t seem to continue to improve outcomes as volume rises. Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos GM. Perioperative safety and volume: outcomes relationships in bariatric surgery: a study of 32,000 patients. J Am Coll Surg. 2011 Dec;213(6):771-7
  • 20.  “Indemnity” : reimbursement or to compensate  Only civil not criminal negligence  legal liability claims  Defense cost :Expenditure  Can insure whole team  Unqualified staff errors, omissions, negligence  No cover weight reduction drugs
  • 21. Total 64 Bariatric surgeon •New India assurance:15 •United insurance: 13 •National insurance: 8 •Oriental insurance: 6 •Don’t know : 22
  • 22.  Member of obesity society  Protocol based practice (guidelines ASMBS)  Proper documentation  Consent – continuous process  Second opinion – in case of doubt or complications  Insist for workshop certificates mentioning types and no of surgeries.  Insure yourself

Notes de l'éditeur

  1. Most of you will wonder what this picture doing here.......next few minutes we shall be discussing about its significance.... So as a bariatric surgeon we have learned two things from airline industry 1. Zero % error before takeoff ....during flight.......during landing (Documentation, security check, safety instruction) in simple words “definate Sequence of events” what we call “Protocol” 2. First secure yourself before helping other I hope my half of the job is done here.......... So we shall be discussing about Medico legal aspects of Bariatric surgery and what we have learnt from past so as to minimize lawsuits
  2. Now this interesting case has set benchmark for medico legal cases...........but irony for doctors.
  3. Anuradha saha (child psychologist) Kunal saha an MD from US (HIV) Mild rash due to drug allergy “Toxic epidermal necrolysis” Depomedrol (long acting steroid,max dose 40-120 mg @1-2 wks interval) she was give that about 15 times its normal usage.Treating doctor went to US with anuradha still admitted in hospital under three other physcian her skin started peeling off and was air lifted to mumbai from kolkata where she breathed her last.it took 15 years for this battle
  4. In a medical negligence cases it is for the patient to prove with evidence against medical professional, and not for the medical professional to prove that he acted with sufficient care and skills.
  5. Like unavailability of Oxygen cylinder in Emergency
  6. This claims are not overall reflection of all lawsuits against bariatric surgeon in US. Data collected from attorney general
  7. Ask yourself do I have infrastructure ,equipments and compatible team if your answer is no than forgive me for being harsh but have no right to play with human life
  8. Process of consent starts from your first encounter with patients and it goes on for years. now as far as documentation of Consent is concerned, In the court of law where judges have No idea about medical terminology (So, use simple language, elaborative may be 10 pages)all pages should be numbered and each page of consent need to be signed by patient,relative and surgeon (Not Medical officer).
  9. Provide Realistic Risk Estimates :patient factors and institutional and health provider characteristics (experience and outcomes) unknown or unforeseeable long-term risks
  10. In the court of law First question that is asked to an Bariatric surgeon is “qualification and experience as an bariatric surgeon”. if you are not a board certified bariatric surgeon and even you have done 100 cases ,the court will raise question about your “Formal training as bariatric surgeon” Training can be fellowship or non fellow with 100 cases  primary or secondary surgeon under supervision of mentor but not as an observer.
  11. This is a small survey I conducted for all OSSI members and received 64 response, this figure itself indicate “”how casual we are toward our own safety” we take things granted and suddenly we find our self in trouble . All Three were NEW India Assurance (2 good experience,1Pathetic ) in terms of settlement. if this three person want to share their experience they are welcomed during discussion.
  12. Litigation is a constant concern in the performance of bariatric surgery, despite every precaution. Problems can arise with patient selection and preparation, surgeon qualification, inadequate documentation, hospital qualification, the inherent risks of the operations, and the aftercare of the operations. And that is why Bariatric surgery has been a popular target of plaintiff attorneys. The law like medicine is an inexact science, one can not predict with certainty an outcome in many cases. it depends on particular fact and circumstantial evidences and also on the personal notions of the judge hearing the case. two things should be kept in mind Judges are laymen  they rely on testimony of specialist, which may not be objective in all cases Specialist opinion is not a binding for judgment.